MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem Component Incompatible (1108)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The olympus asset device, evis exera iii xenon light source, was sent to the olympus service center.Upon inspection and testing of the returned device, it was discovered non-olympus designated lamps were used.There was no patient involvement.

Manufacturer Narrative

The asset device was returned to olympus.Upon inspection testing of the returned device, the use of non-olympus designated lamps was discovered.In addition, it was noted, the top cover and front panel were discolored/scratched, the connector socket was worn out and the non-olympus lamp life was over 500hrs.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been over 8 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a root cause could not be identified.No further information was available.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The cause of the reported event cannot be conclusively determined.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15762852
• MDR Text Key: 307769770
• Report Number: 3002808148-2022-03981
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170304835
• UDI-Public: 04953170304835
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 12/02/2022
• Supplement Dates FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1